QC Chemist I

BD • San Diego, CA

263d • $28 - $47

About The Position

Perform routine analytical chemistry functions in support of GMP production activities for the manufacture of therapeutic proteins, antigens, vaccines or other products. Conduct assigned analyses according to established protocols and procedures using appropriate equipment and reagents. Interpret results to ensure compliance with specifications. Maintain documentation required by cGMP regulations. Perform analysis on raw materials, packaging materials and/or finished products from manufacturing to ensure compliance with regulatory agency requirements prior to release. Troubleshoot product and process related issues involving impurities, stability, formulation, and labeling. May participate in cross-functional teams, perform project work, and provide technical leadership as needed. The Quality Control Chemist I conducts various analytical testing of raw materials, semi-finished intermediates, finished products, and new compounds/products in various stages of design and development to characterize and determine quality.

Requirements

• BS degree in Chemistry, Biochemistry, Biology or relevant science discipline.
• MS preferred.
• Experience in a GMP environment preferred.
• Knowledge of biologics, small molecules, purification processes and experience in method development preferred.
• Basic understanding of chromatography and electrophoresis.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).
• Ability to multitask efficiently.
• Must be able to work independently, as well as part of a team.

Nice To Haves

• Laboratory experience including HPLC, GC, ELFA, spectroscopy, plate reader, etc.
• Experience with protein characterization methods such as Western blots, SDS PAGE, mass spec, etc.
• Knowledge of FDA and cGMP guidelines.
• Experience in a GLP or GMP facility.

Responsibilities

• Characterize polymer size by GPC/SEC chromatography using established standard processes.
• Perform small scale dye labeling reactions according to established standard processes.
• Characterization of polymers by HPLC/FPLC using established standard processes.
• Optical characterization of the polymer dyes including measurement of absorbance and fluorescence emission spectra.
• Provide analysis and evaluation of material and products at all stages of development process.
• Participate in validation and measurement system analysis of various testing methods.
• Maintain equipment logs, calibration logs, and solvent/mobile phase preparation records.
• Test products for long-term stability under various conditions.
• Provide timely and high-quality data reports that document test results.
• Interface, maintain, and populate data and results in specified database(s).
• Promote a safe work environment.
• Participate in Environmental Health and Safety programs.
• Address corrective actions whenever a hazard is identified.
• Notify supervisor of all observed hazardous conditions or unsafe work practices.
• Other responsibilities or projects as assigned by reporting manager.

Benefits

• Competitive salary and hourly rate.
• Opportunities for performance-based rewards and recognition.
• Support for associates' well-being and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree